Bioavailability of BI 144807 Given Alone and in Combination With Ketoconazole in Healthy Male Volunteers

Relative Bioavailability of a Single Oral Dose of BI 144807 (Oral Solution) When Administered Alone or in Combination With Multiple Oral Doses of Ketoconazole (200 mg Tablet) in Healthy Male Subjects (an Open-label, Two-period, Fixed-sequence Trial)

This trial investigates the influence of oral ketoconazole on the pharmacokinetics and safety of BI 144807.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BI 144807; Drug: Ketoconazole

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Biberach, Germany
    • 1313.7.1 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion criteria:

1. healthy male subjects

Exclusion criteria:

1. any relevant deviation from healthy conditions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BI 144807; subjects receive an oral single dose of BI 144807	Drug: BI 144807; BI144807 oral solution, intermediate dose
Experimental: BI 144807 plus Ketoconazole; subjects receive bid ketoconazole plus an oral single dose of BI 144807	Drug: BI 144807; BI144807 oral solution, intermediate dose; Drug: Ketoconazole; Ketoconazole 400 mg / day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity	0 to 48 hours after administration
Maximum measured concentration of the analyte in plasma	0 to 48 hours after administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point	0 to 48 hours after administration

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: October 15, 2012
• First Submitted That Met QC Criteria: October 15, 2012
• First Posted (Estimate): October 16, 2012

Study Record Updates

• Last Update Posted (Estimate): May 16, 2013
• Last Update Submitted That Met QC Criteria: May 15, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Ketoconazole
• Other Study ID Numbers: 1313.7; 2012-003225-21 (EudraCT Number: EudraCT)